TrainFES 先进型医疗设备
K号: K241488 · 2025-02-05
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申请人Trainfes
决定日期2025-02-05
产品代码IPF
咨询委员会PM
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决定实质等同
器械摘要
TrainFES Advance is the device name listed in this FDA 510(k) record. The listed applicant is Trainfes. It received FDA 510(k) clearance on 2025-02-05 under 510(k) number K241488. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TrainFES Advance?
TrainFES Advance is a medical device that received FDA 510(k) clearance on 2025-02-05. The listed applicant is Trainfes. The 510(k) number is K241488.
When did TrainFES Advance receive FDA 510(k) clearance?
TrainFES Advance received FDA 510(k) clearance on 2025-02-05, under 510(k) number K241488.
Who is the listed applicant for TrainFES Advance?
The FDA 510(k) record lists Trainfes as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TrainFES Advance?
The FDA product code for TrainFES Advance is IPF.
相关临床试验
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相关器械（代码：IPF）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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